BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2020708 · Received March 16, 2011

    Report

    Report Number
    2020708
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    June 7, 2010
    Report Date
    May 31, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: FAULTY CONTROLLER-UNEXPLAINED ALARMS. SPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION. ADDITIONAL TEXT: FAULTY CONTROLLER. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURESPECIFIC COMPONENT(S) INVOLVED: EXTERNAL CONTROLLER MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45.5 YR